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510(k) K933005

AVI MODEL 600 SYRINGE PUMP by 3M Health Care, Ltd. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1993
Date Received
June 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (January 7, 1994)
  • K932422 — 3M TEGADERM HP TRANSPARENT DRESSING (December 27, 1993)
  • K932446 — INJECTION SITE (November 29, 1993)
  • K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (November 10, 1993)
  • K933006 — AVI INFUSION PUMPS, ADDITIONAL INTENDED USE (October 25, 1993)

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